Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules
Purpose
This study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.
Conditions
- Nodule Solitary Pulmonary
- Non-small Cell Carcinoma
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements 2. Subject is > 40 years of age at the time of the discovery of the lung nodule of concern 3. Subject's lung nodule of concern meets the following: - Was incidentally identified or detected during lung cancer screening - Is a solid nodule - Has maximal dimension of > 8mm and < 30mm 4. The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment 5. The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less
Exclusion Criteria
- Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure or blood-based testing for the lung nodule of concern 2. Nodule of concern is part-solid or Ground Glass Opacity (GGO) 3. Prior diagnosis of lung cancer 4. Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer 5. Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment 6. Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern 7. Any illness or factor that will inhibit compliance with study participation
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Open Label | Nodify XL2 results will be reported to the investigator and available to the subject. | |
| Blinded | Nodify XL2 results will not be available to the investigative site or subject. |
Recruiting Locations
University of Texas Medical Branch
Galveston, Texas 77555
Galveston, Texas 77555
Contact:
Cindy Mitchell
Cindy Mitchell
More Details
- Status
- Recruiting
- Sponsor
- Biodesix, Inc.
Detailed Description
A multicenter, randomized controlled study with a blinded control arm. Open label arm is observational for lung nodule management. The clinical trial will evaluate the clinical utility of the Nodify XL2 integrated classifier when used in the clinical management of newly identified solid lung nodules assessed as < 50% risk of cancer by Mayo risk prediction algorithm.